- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Job DescriptionOur Regulatory Affairs team bring new medical...activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....the Oncology drug development preferred.Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist… more
- Eisai, Inc (NJ)
- …a difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs ... Salary Transparency Language:The base salary range for the Medical Director , US Medical Affairs , Neurology...the employment eligibility of all new hires in the United States . Please click on the following… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … & Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our current portfolio and robust ... Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states and DC, with a focus… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... for collecting, analyzing, synthesizing and communicating intelligence relating to the US regulatory framework. Regulatory PolicyScans the horizon… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... If this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive… more
- Merck & Co. (Rahway, NJ)
- …multiple internal stakeholders across HH, our Research & Development Division, Medical Affairs , Regulatory , Legal etc. as well as external partners (diagnostic ... pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are...of the digital pathology tools in collaboration with Medical Affairs and our Research & Development Division Education: Bachelor's… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Tris Pharma (Monmouth Junction, NJ)
- …The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality, etc. to identify, evaluate ... individual case reviews, assessment of expectedness and relatedness; Collaborates closely with Regulatory Affairs or appropriate vendors on expedited reports, as… more
- Merck & Co. (Rahway, NJ)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services Project Management and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …learning and personal development. Are you ready to maximize your potential with us ? The Position Responsible for the development and execution of data strategies ... focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include… more
